MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER; TEMPERATURE SENSING CATHETER (SILICONE)

Model Number 119314

Device Problems Leak/Splash (1354); Decrease in Pressure (1490)

Patient Problem Abdominal Pain (1685)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the patient complained of abdominal pain during the placement and the balloon was removed once.It was also stated that water leak was found later.

Event Description

It was reported that the patient complained of abdominal pain during the placement and the balloon was removed once.It was also stated that water leak was found later.

Manufacturer Narrative

The reported event was confirmed as manufacturing-related.Visual inspection noted one temperature sensing catheter with a cut portion of the inlet tubing was received.Visual evaluation noted no obvious defects.Attempted to inflate the catheter's balloon with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the solution immediately leaked out of the eyelets.The balloon was dissected to find that the inflation notch perforated both lumens.This fails to meet specifications as "eye punching must not penetrate the inflation, irrigation lumen and/or thermistor." although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be punch depth too large.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10570179
• MDR Text Key: 208590149
• Report Number: 1018233-2020-06138
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039843
• UDI-Public: (01)00801741039843
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 119314
• Device Catalogue Number: 119314
• Device Lot Number: NGEQ2217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1